Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT04888702

Holter of Movement in Patients with SMA Undergoing Treatment.

Holter of Movement in Patients with Type 2 or 3 Spinal Muscular Atrophy When Initiating Treatment with Spinraza ° or Risdiplam. Acti-SMA Study.

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
30 (estimated)
Sponsor
Centre Hospitalier Universitaire de Liege · Academic / Other
Sex
All
Age
6 Years
Healthy volunteers
Not accepted

Summary

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.

Conditions

Interventions

TypeNameDescription
DEVICEActimyoActimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

Timeline

Start date
2018-08-08
Primary completion
2025-01-30
Completion
2025-05-30
First posted
2021-05-17
Last updated
2025-02-12

Locations

3 sites across 2 countries: Belgium, Romania

Source: ClinicalTrials.gov record NCT04888702. Inclusion in this directory is not an endorsement.